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Why drug importation threatens patient safety

Counterfeit drug manufacturing and trafficking is a multi-billion dollar business. Legislative proposals to allow importation of potentially counterfeit and substandard drugs into the United States are unsafe and put American patients at risk. This is because the U.S. government cannot guarantee that medicines entering the country via importation schemes will meet our strict safety standards. Here’s a closer look at why these proposals put patient safety at risk:

The United States is the gold standard when it comes to regulating the safety of our medicine supply. The U.S. Food and Drug Administration’s extensive regulations governing the security of our closed supply chain play a critical role in helping keep counterfeit medicines from infiltrating the U.S. prescription medicine system. Without this federal oversight, unapproved drugs could be mixed into the U.S. drug supply.

Other countries cannot and will not ensure the safety and efficacy of prescription drugs entering the United States from abroad. In fact, the National Association of Boards of Pharmacy found that 96 percent of 10,000 online drug sellers were not in compliance with U.S. pharmacy laws and standards. Of those drug sellers not in compliance, 88 percent did not require a valid prescription and 91 percent appeared to have affiliations with fraudulent or illegal online pharmacies.

Even drugs that supposedly come from Canada are frequently not made or processed there, but actually come from countries with lax regulatory systems. As CNN reported, quoting an online seller from Pakistan, “We sell all over the world, to America, Europe, China, Iran and Iraq. All over. But we do not take these medications ourselves, nor do we recommend them to anyone we know, because they are not good quality medications.”

Allyson Funk Ally is a former senior director of public affairs at PhRMA focused on advocacy issues for the biopharmaceutical industry. Her expertise includes Medicare, Medicaid, 340B, health reform and more. Prior to PhRMA, her experience included leading health communications for a large membership organization, supporting public affairs clients and working for the governor of Louisiana.